Your Partner in Global UDI Compliance
UDI Experts — The Global Center for Strategic UDI Solutions and More! We deliver Unique Device Identification data solutions for medical device and in-vitro diagnostic manufacturers: UDI strategy, Device Identifier assignment, labeling compliance, printer qualification, registry submissions, data governance, and training across 13 countries.
UDI compliance services
- FDA GUDID submission services — HL7 SPL submissions through the FDA Electronic Submissions Gateway, preparation and validation of up to 65 data elements per device record, and correction cycles worked through to publication.
- EUDAMED UDI consulting — actor registration and SRN support, Basic UDI-DI architecture, device registration, and legacy device remediation ahead of the 28 November 2026 deadline.
- UDI labeling compliance — label content and format review against FDA 21 CFR 801 and EU MDR, human-readable and AIDC formats, date formats, and direct marking assessment.
- Printer qualification and design controls — remote IQ/OQ/PQ for in-house label printers per 21 CFR Part 11, plus User Needs, Design Inputs, Trace Matrix, and Design Transfer.
- UDI for Highly Individualized Devices — Master UDI-DI implementation for contact lenses, spectacle lenses, frames, and ready-to-wear reading spectacles.
- Data system selection — ERP, PIM, and MDM systems that integrate with UDI submission workflows.
- Data maintenance and governance — change control that flags UDI-triggering changes, record updates, and audit preparation.
- UDI staff augmentation and training — experienced consultants embedded in your team, and structured training with hands-on GUDID and EUDAMED work.
Free UDI tools
Our free UDI decoder parses GS1 Application Identifiers and validates GTIN-14 check digits in your browser. The site also offers a label checker, a compliance plan generator, a UDI readiness assessment, and a UDI AI assistant. All free, no account required, and nothing you enter is uploaded or stored.
Where UDI is required
United States (FDA GUDID), European Union (EUDAMED — mandatory since 28 May 2026), Switzerland (swissdamed — mandatory since 1 July 2026), Australia (TGA AusUDID — Class III and IIb since 1 July 2026), China (NMPA UDID), South Korea (MFDS IMDIS), Saudi Arabia (SFDA Saudi-DI), Taiwan (TFDA TUDID), Türkiye (ÜTS), Japan (PMDA), Brazil (ANVISA), Singapore (HSA SMDR), India (CDSCO), and the United Kingdom (MHRA, in development).
Key UDI deadlines
- 28 November 2026 — EU: legacy devices still being supplied must be registered in EUDAMED.
- 1 July 2027 — Australia: Class IIa devices enter scope for UDI compliance.
- 27 May 2027 — EU: notified bodies must upload pre-existing certificates to EUDAMED.
- 1 July 2028 — Australia: Class Is devices and high-risk IVDs enter scope.
About UDI Experts
Founded in 2018 by Hussam Mostafa, UDI Experts focuses exclusively on Unique Device Identification. Our team brings experience from Baxter, Pfizer, Hospira, and ICU Medical, currently supports a Fortune 50 technology company's UDI programme, and participates in GS1 working groups developing GTIN allocation rules and the Master UDI-DI solution. Read more about us.
Contact
Chicago area, Illinois, USA. Phone +1.224.259.9092. Email support@udiexperts.com. Scoping conversations are free and usually take thirty minutes.